Regulatory Information

Our Commitment is Patient Safety, Product Quality, and Innovative Research & Development

Complying with Federal, State and local regulations is essential to ensure patient safety and promote public trust. Regenerative Processing Plant (RPP) is registered with the U. S. Food and Drug Administration (FDA).
RPP has filed applications with all governing entities that may require licensure, registration and/or certification and our associate processing facility is ISO 13485: 2003 certified.

Regenerative Processing Plant is committed to providing the medical community with innovative regenerative products manufactured under current Good Manufacturing Practices (cGMP) regulated by the FDA. All of RPP’s products are manufactured under the guidelines of 21 CFR; Part 1271; section 361 of the Public Health Act.

Donor Quality and Screening for Patient and Product Safety:

Regenerative Processing Plant utilizes a laboratory registered with the FDA to perform Communicable disease donor testing and is certified to perform such testing on human specimens in accordance with Clinical Laboratory Improvement Amendments (CLIA) and 42 CFR Part 493, or that has equivalent requirements as determined by the Centers for Medicare and Medicaid Services. Communicable disease testing has been performed, names and addresses of testing laboratories, interpretation of all required infectious disease tests, and a listing of the documents reviewed as part of the relevant medical records are kept on file at RPP and are made available upon request.

Blood samples were given by the donor prior to or at the time of collection and were tested by laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) and were found negative using FDA licensed tests for, at minimum:

HBsAg: Hepatitis B Surface Antigen

HBcAb: Hepatitis B Core Antibody

HCVAb: Hepatitis C Antibody

HIV 1/2/Ab: Human Immunodeficiency Virus Types 1/2 and O Antibody

HCV NAT: Hepatitis C Virus

HIV NAT: Human Immunodeficiency Virus

HBV NAT: Hepatitis B Virus

RPR/STS or Equivalent: Syphilis

Downloadable Forms

Regenerative Processing Plant, LLC

Form FDA 3356 as of February 2, 2015 – Please call to request (800) 781-0818

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About Us

Regenerative Processing Plant, LLC (RPP), was founded on a simple principle, “follow the science”. This single standard has since become our charter and has helped place RPP at the forefront of regenerative product advancement. Our mission statement is summarized by our slogan “Science Based Regenerative Advanced Technologies for Humanity tm." RPP is committed to a full line of regenerative products designed to advance the body’s ability to heal.